Cancer drug trial begins

32 patients to take EntreMed Endostatin in 2nd of 3 FDA tests

November 29, 2001|By Julie Bell | Julie Bell,SUN STAFF

EntreMed Inc. said it began a clinical trial yesterday in which cancer patients are injecting themselves at home with the anti-tumor drug Endostatin.

The trial, for patients with neuroendocrine tumors, is the latest step in the company's attempt to develop cancer drugs that are free of side effects. The aim is to make cancer a manageable disease, much like diabetes.

EntreMed expects 32 patients to enroll in the Endostatin trial at Dana-Farber Cancer Institute in Boston. The Phase II trial, focused on measuring the drug's effectiveness, is the second of three phases of human testing required by the Food and Drug Administration. Previous trials focused on the drug's safety.

Neuroendocrine tumors often are classified as pancreatic endocrine or carcinoid tumors. About 8,400 cases of those kinds of cancer are diagnosed annually, EntreMed said. To put the number in perspective, the American Cancer Society estimated that 1.2 million cases of cancer would be diagnosed in 2000.

EntreMed has received "orphan drug" designation for Endostatin as a treatment for neuroendocrine cancers. The marketing and financial advantages that come with the federal designation are designed to encourage the development of drugs for diseases affecting fewer than 200,000 Americans. The advantages include tax incentives and seven years of marketing exclusivity.

Once a drug is on the market for one use, however, physicians can prescribe it however they see fit, EntreMed Chief Executive Officer John Holaday noted. The Celgene Corp. drug thalidomide, for example, is approved only for leprosy in the United States but increasingly is being prescribed as a treatment for multiple myeloma, a blood cancer.

The trial marks the first Phase II trial of Endostatin in which patients injected themselves at home. Patients participating in a Phase I trial in the Netherlands of a sister drug known as Angiostatin have used the method.

Last month, independent doctors overseeing that trial reported that a number of individual patients who injected themselves with Angiostatin had stable disease for months. But none of the 24 patients saw tumors shrink substantially. Both drugs are designed to choke off a tumor's blood supply.

Shares of EntreMed lost 40 cents yesterday to close at $10.87.

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